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The findings of a new study raise concerns about the use of NSAID painkillers, such as Advil, Motrin, Aleve and others common drugs, among patients who are already taking anticoagulants, such as Xarelto, Pradaxa or warfarin, suggesting that the combined use may further increase the risk of bleeding problems.
Researchers from the Denmark published a study in the Annals of Internal Medicine on November 18, which found that patients being treated with blood thinners for atrial fibrillation face an increased risk of bleeding when they also use nonsteroidal anti-inflammatory drugs (NSAIDs).
The study looked at data on 150,900 patients with atrial fibrillation who were prescribed an NSAID. Researchers found that within 14 days of taking NSAIDs in combination with anticoagulants, 2.5 more patients who suffered a severe bleeding event per 1,000 patients than if they had not been given an NSAID. The findings did not appear to be related to what type of NSAID or what type of blood thinner patients were given.
The findings also suggested that NSAID use increased the risk of thromboembolism events as well, such as deep vein thrombosis and pulmonary embolism.
The effects appear to be dose-specific, meaning that the more NSAIDs a patient took, the more likely they were to suffer a serious bleeding event while taking the anticoagulant as well. Such dose-specific responses are generally considered a strong indicator of a causal relationship.
“Use of NSAIDs was associated with increased absolute risks for serious bleeding and thromboembolism across all antithrombotic regimens and NSAID types,” the researchers determined. “An NSAID dosage above the recommended minimum was associated with a substantially increased hazard ratio for bleeding.”
New Anticoagulant Bleeding Concerns
The findings come amid increasing concerns about the risk of severe bleeding events associated with a new generation of anticoagulants that have been introduced in recent years as replacements for warfarin, which has been the most commonly prescribed blood thinner for atrial fibrillation patients for years.
All blood thinners carry a bleeding risk, as the medications are designed to prevent clotting, which can make bleeds difficult to control. However, a new generation of blood thinners have been widely adopted in recent years, including Xarelto, Pradaxa, and Eliquis.
Unlike warfarin, which can be quickly reversed with a dose of vitamin K and fresh frozen plasma in the event the bleeding develops, allowing blood to clot, there is no approved reversal agent for Xarelto, Pradaxa or Eliquis, which often leaves doctors unable to control bleeding problems, potentially increasing the risk of more serious injury or death.
When Pradaxa was first released it quickly became associated with a high number of adverse event reports to the FDA and hundreds of bleeding deaths in the U.S. alone.
More than 4,000 Pradaxa lawsuits were ultimately filed against Boehringer Ingelheim, alleging that the drug maker failed to adequately research the medication and withheld proper warnings about the bleeding risk and lack of a reversal agent.
Following several years of litigation, the drug maker agreed to pay $650 million in Pradaxa settlements earlier this year, with an average of about $150,000 paid to resolve claims brought on behalf of former users who experienced injuries from uncontrollable bleeds.
As concerns about the safety of Pradaxa mounted, Xarelto has grown to become the most widely used of the new-generation anticoagulants. However, similar reports of Xarelto bleeding problems have surfaced, with users experiencing uncontrollable gastrointestinal hemorrhaging and death.
Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary now face a growing number of Xarelto lawsuits, which raise similar allegations to those presented in the Pradaxa.
Many of the claims indicate that the drug makers failed to adequately explore all potential reversal agents, suggesting that Xarelto should be removed from the market until a safe and effective antidote for bleeding problems is identified.